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The call conveyed meaningful, tangible progress toward a key inflection point: CORDStrom advanced through regulatory planning (PIP approval), manufacturing validation runs began, and a long-term supply agreement was secured — all supportive milestones. XPro imaging work and partnership exploration were also positive. Offsetting these positives are schedule/regulatory timing shifts, a materially limited cash runway (funding through Q1 2027), and a large year-over-year reduction in R&D spend that could indicate slower near-term investment. Overall the call shows constructive execution on regulatory and manufacturing fronts but meaningful financing and execution risks remain.
Management guided that CORDStrom remains on track for regulatory filings, expecting to submit to the U.K. MHRA in early Q3 2026 and to pursue parallel EMA/FDA submissions (TMC Pharma retained) with an end‑of‑year 2026 filing target and commercial manufacturing/supply planned for 2027; manufacturing validation has begun (first of 3 process‑validation runs started on time, two remaining scheduled), the pediatric investigation plan received a rapid assessment with regulator response on April 9 and a final response due shortly, and an amended material transfer agreement with Anthony Nolan to secure umbilical cord supply was signed; financial guidance/metrics included Q1 2026 net loss of ~ $5.4M (vs. ~$9.7M Q1 2025), R&D spend of ~ $3.6M (vs. ~$7.6M), G&A of ~ $2.2M (vs. ~$2.3M), cash and cash equivalents of ~ $21.4M as of March 31, 2026 with runway into Q1 2027, and ~26.6M shares outstanding as of May 7, 2026.
Submitted Pediatric Investigation Plan (PIP) to U.K. regulator; approved for rapid assessment with response received April 9 and no substantial issues raised. Marketing Authorization Application (MAA) documentation across five sections is well underway; company expects to submit to MHRA in early Q3 and is targeting parallel EMA/FDA filings to meet the previously stated end-of-year filing timeline.
Started the first of three process validation manufacturing runs on time, with two remaining runs scheduled to meet MAA deadlines. Concluded and signed an amended material transfer agreement with the Anthony Nolan U.K. Cord Blood Bank to secure long-term, high-quality umbilical cord tissue supply and permit U.S. lab testing required by the FDA (per prior Type B meeting).
Active ingredient named by WHO as pobistrocel and company selected commercial drug name Ebstracel for the RDEB formulation; preparing regulatory and commercial documentation and engaging TMC Pharma (rare disease submission expertise) to run EMA and FDA submissions in parallel.
Advancing additional imaging analyses from the MINDFuL study, including MRI data focused on myelin preservation and structural integrity to further characterize XPro's potential as a disease-modifying therapy; exploring rare disease trial opportunities and partnership discussions for late-stage development.
Net loss attributable to common stockholders for Q1 2026 was $5.4 million versus $9.7 million in Q1 2025, a reduction of approximately 44.3% year-over-year, reflecting lower operating spend this quarter.
R&D expenses decreased to $3.6 million in Q1 2026 from $7.6 million in Q1 2025 (approximately a 52.6% reduction). General and administrative expenses were roughly flat at $2.2 million versus $2.3 million (about a 4.3% decrease). Cash and cash equivalents were $21.4 million as of March 31, 2026, and management believes cash is sufficient to fund operations through Q1 2027; shares outstanding were ~26.6 million as of May 7, 2026.
Greetings, and welcome to the INmune Bio's 2026 First Quarter Earnings Call. As a reminder, this conference is being recorded. A transcript will follow within 24 hours of this conference call. At this time, it is my pleasure to introduce Mr. Daniel Carlson, Head of Investor Relations of INmune Bio.
Thank you, operator, and good afternoon, everyone. We thank you for joining us for the call for INmune Bio's 2026 First Quarter Financial Results. Presenting on today's call are David Moss, CEO and Co-Founder of INmune Bio; Dr. Mark Lowdell, Chief Scientific Officer and Co-Founder of INmune Bio; and Cory Ellspermann, INmune Bio's CFO. Before we begin, I remind everyone that except for statements of historical fact, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those such as forward-looking statements. Please see the forward-looking statements disclaimer on the company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filings with the SEC. There is no assurance of any specific outcome.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, INmune Bio disclaims any obligation to update the...